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NCT03259308 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 279
- Enrollment target
NCT03259308: Clinical Trial Phase 3 study, sponsored by Shire.
NCT03259308 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 279 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259308, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 279 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Primary Outcome
Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ul
Interventions
- DRUG Placebo
- DRUG Ontamalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2017-12-05 |
| Est. Completion | 2020-10-06 |
| Phase | Phase 3 |
Why NCT03259308 stopped before completion
NCT03259308 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03259308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03259308 about?
NCT03259308 is a clinical study titled "Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
What is the current status of trial NCT03259308?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2017-12-05. Estimated completion is 2020-10-06.
What interventions are being tested in trial NCT03259308?
The interventions under investigation include: Placebo (DRUG), Ontamalimab (DRUG).
Who is sponsoring clinical trial NCT03259308?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03259308's enrollment target sits among peer trials
279 1199th of 2000 higher than 801 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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